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May 1, 2025
by Jason Scott

Recon: RFK Jr. will reportedly require placebo-controlled studies for new vaccines; WHO to support use of weight-loss drugs worldwide

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • RFK Jr. will order placebo testing for new vaccines, alarming health experts (Washington Post) (CNN)
  • US FDA Commissioner’s Office Plans Involvement In Many Approvals In Potential Major Change (Pink Sheet)
  • FDA to rehire fired staffers who booked inspection trips, but other workers remain in limbo (AP)
  • Collins and fellow GOP senators speak out in opposition to Trump’s cuts to biomedical research (STAT)
  • Lilly meets sales expectations, but Novo gains on PBM win (Endpoints)
  • BeiGene scores a win from US Patent Office in spat over Brukinsa (Endpoints)
  • Moderna expands effort to rein in costs in an ‘uncertain environment’ (Endpoints)
  • Moderna says FDA has been constructive, but delays flu/COVID shot (Reuters)
  • Exits continue at FDA, as more staff in drug office follow fired colleagues out the door (Endpoints)
  • US drugmakers increasingly look abroad for clinical trials as confidence in FDA wavers (Endpoints)
In Focus: International                                                                                                       
  • Exclusive: WHO to back use of weight-loss drugs for adults globally, raises cost issue (Reuters)
  • Global health funding faces 'greatest disruption' in memory, says WHO director (Reuters)
  • Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence (Pink Sheet)
  • UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up (Pink Sheet)
Pharma & Biotech
  • Novo Nordisk strikes telehealth deals for obesity drug, following Eli Lilly (STAT)
  • Eli Lilly downplays CVS move to drop Zepbound coverage, shares plunge (Reuters)
  • M&A is back, but nothing in biotech is neat or simple (STAT)
  • Biogen says Leqembi sales are improving slowly following lackluster launch (Endpoints)
  • Exclusive: Ex-Calico scientist launches Stately Bio with new way to study cells (Endpoints)
  • Arvinas ends plans for two Phase 3 breast cancer trials; Phathom makes cuts (Endpoints)
  • After hunt for alternatives, Kronos Bio selects Tang Capital's Concentra for a deal (Endpoints)
  • Amicus grabs Dimerix’s rare kidney disease drug for $30M upfront (Endpoints)
  • Biogen's results beat estimates on strength in rare disease drugs (Reuters)
  • Cardinal Health sees up to $300 million tariff hit in fiscal 2026 (Reuters)
  • Another Regeneron CRL Prompts Regulatory Operations Questions (Pink Sheet)
Medtech
  • Teladoc buys virtual therapy startup UpLift for $30M (Endpoints)
  • Exclusive: Noma Therapy raises $4M for virtual ketamine-assisted therapy (Endpoints)
  • Baxter tops quarterly estimates on strong demand for medical devices (Reuters)
  • Medical device maker Becton Dickinson cuts 2025 profit forecast on potential tariff hit (Reuters)
Food & Nutrition
  • Nestlé changes how it reports nutritional value of food after criticism (Food Dive)
  • FDA Suspends Milk Quality Testing Amid Health and Human Services Cuts (Food Safety)
Government, Regulatory & Legal
  • Trump administration banned chosen names at FDA, CDC, NIH under new gender policy (USA Today)
  • CVS Health’s Aetna to abandon Affordable Care Act insurance marketplaces, again (STAT)
  • RFK Jr.’s synthetic dye bans miss a much bigger problem (STAT)
  • Why NIH’s policy on grants to universities with DEI programs is not cause for widespread alarm (STAT)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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